The Impact of Surgical Technique on Circulating Tumor DNA in Stage I-III Non-Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This clinical trial compares the effect of pulmonary vein-first surgical technique to pulmonary artery-first surgical technique in decreasing circulating tumor cell deoxyribonucleic acid (ctDNA) in patients with stage I-III non-small cell lung cancer. Pulmonary vein first and pulmonary artery first surgical techniques are standard surgical techniques for the division of the blood vessels during lung resection surgery. Pulmonary vein-first surgical technique may reduce the risk of shedding tumor cells during surgery and influence long term overall survival.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
PRIMARY OBJECTIVE:
- To determine the association between sequence of surgical resection and postoperative ctDNA levels at specified time points.
SECONDARY OBJECTIVE:
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To determine the associated between sequence of surgical resection and postoperative ctDNA level and clinical oncologic outcomes.
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To assess disease-free survival and the role of circulating tumor DNA in disease recurrence in patients with resectable non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo pulmonary vein first approach surgical procedure on day of surgery.
GROUP II: Patients undergo pulmonary artery first approach surgical procedure on day of surgery.
After completion of surgery, patients are followed up at day 1, day 7, days 7-28, 4 months, every 6 months for 2 years, then every 6 months for up to 5 years
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group I (pulmonary vein first approach procedure) Patients undergo pulmonary vein first approach surgical procedure on day of surgery. |
Procedure: Pulmonary Artery-First Surgical Technique
Undergo pulmonary artery first surgical technique
Other Names:
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| Active Comparator: Group II (pulmonary artery first surgical procedure) Patients undergo pulmonary artery first approach surgical procedure on day of surgery. |
Procedure: Biospecimen Collection
Correlative studies
Other Names:
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Outcome Measures
Primary Outcome Measures
- Circulating tumor deoxyribonucleic acid (ctDNA) status [At postoperative day 2]
Stratified by surgical vascular division technique. A peripheral blood sample will be taken at the time of surgery to determine baseline ctDNA status. Following surgical resection a blood sample will be taken at specified time points (postoperative day 2; postoperative day 14) to determine ctDNA levels compared to baseline. The difference in the proportion of patients who have positive ctDNA status between those undergoing division/ligation in a "pulmonary-vein first" technique compared to a "pulmonary-artery first" technique will be estimated. The risk difference will be estimated along with a 95% confidence interval.
- Circulating tumor deoxyribonucleic acid (ctDNA) status [At postoperative day 14]
Stratified by surgical vascular division technique. A peripheral blood sample will be taken at the time of surgery to determine baseline ctDNA status. Following surgical resection a blood sample will be taken at specified time points (postoperative day 2; postoperative day 14) to determine ctDNA levels compared to baseline. The difference in the proportion of patients who have positive ctDNA status between those undergoing division/ligation in a "pulmonary-vein first" technique compared to a "pulmonary-artery first" technique will be estimated. The risk difference will be estimated along with a 95% confidence interval.
Secondary Outcome Measures
- Disease free survival rate [Up to 5 years]
The distribution of survival outcomes will be estimated using the Kaplan-Meier method, stratified by ctDNA status at 2 days and 2 weeks. Key statistics (median survival, 1- and 2-year survival) will be estimated from the curve along with 95% confidence intervals. We will also use a Cox proportional hazard regression model, stratified by stage in the analyses, to estimate the hazard ratio along with a 95% confidence interval.
- Overall survival rate [Up to 5 years]
The distribution of survival outcomes will be estimated using the Kaplan-Meier method, stratified by ctDNA status at 2 days and 2 weeks. Key statistics (median survival, 1- and 2-year survival) will be estimated from the curve along with 95% confidence intervals. We will also use a Cox proportional hazard regression model, stratified by stage in the analyses, to estimate the hazard ratio along with a 95% confidence interval.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any patients 18 years of age or older with confirmed or suspected early-stage (stage I-III) NSCLC
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Eligible and scheduled for surgical anatomic lung resection (e.g. lobectomy or segmentectomy) as routine clinical care for their disease
Exclusion Criteria:
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Previous cancer diagnosis within 5 years (except ductal carcinoma in situ [DCIS] of the breast, superficial bladder cancer, non-melanoma skin primary, other malignancy that does not require treatment).
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Preoperative chemotherapy, immunotherapy, or radiation therapy
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Receipt of perioperative blood transfusion
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Thomas Jefferson University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22D.435